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Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections? (SHARKLET)

Primary Purpose

Catheter Associated Urinary Tract Infections

Status

Completed

Phase

Phase 1

Locations

Hungary

Study Type

Interventional

Intervention

Sharklet Catheter insertion

Silicone Foley Catheter insertion

About this trial

This is an interventional prevention trial for Catheter Associated Urinary Tract Infections focused on measuring CAUTI, Biofilm, Urinary tract infections, micropattern, Catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient requires a chronic indwelling Foley catheter for at least 3 days.
Catheters will not remain indwelling greater than 30 days at a time
Patient is more than 18 years of age
Patient is able to give informed consent
Patient is able to attend follow-up sessions

Exclusion Criteria:

Patient is less than 18 years of age
Patient is pregnant
Patient with a known allergy to silicone
Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
Patient unable to accommodate the catheter
Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated.
Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
Patient is unable to feel and/or communicate their symptoms
Informed consent is unable to be obtained
Patient is unable or unwilling to comply with the study follow-up schedule
Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study

Sites / Locations

Jahn Ferenc South Pest Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A: Sharklet Catheter

Group B: Silicone Foley Catheter

Arm Description

Patient requiring indwelling urinary catheter will be randomised into Group A or Group B

Outcomes

Primary Outcome Measures

Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)

Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.

Number of symptomatic Urinary tract infections (UTIs) determined by urine culture.

Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.

Secondary Outcome Measures

Incidence of bacteremia

Incidence of bacteremia following CA-SUTI

Incidence of Crustation

Incidence of catheter obstruction/encrustation requiring removal

Incidence of Discomfort

Incidence of significant discomfort/pain requiring removal

Surface analysis of the type of bacteria found on each catheter

Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization

Surface analysis of the amount of encrustation

Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation

Surface analysis of the biofilm formation

Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation

Full Information

NCT ID

NCT02835456

First Posted

July 6, 2016

Last Updated

January 1, 2017

Sponsor

Jahn Ferenc South Pest Teaching Hospital

Collaborators

Cook Group Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT02835456

Brief Title

Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?

Acronym

SHARKLET

Official Title

Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jahn Ferenc South Pest Teaching Hospital

Collaborators

Cook Group Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.

Detailed Description

The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter Associated Urinary Tract Infections

Keywords

CAUTI, Biofilm, Urinary tract infections, micropattern, Catheter

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: Sharklet Catheter

Arm Type

Active Comparator

Arm Description

Patient requiring indwelling urinary catheter will be randomised into Group A or Group B

Arm Title

Group B: Silicone Foley Catheter

Arm Type

Active Comparator

Arm Description

Patient requiring indwelling urinary catheter will be randomised into Group A or Group B

Intervention Type

Device

Intervention Name(s)

Sharklet Catheter insertion

Intervention Type

Device

Intervention Name(s)

Silicone Foley Catheter insertion

Primary Outcome Measure Information:

Title

Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)

Description

Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.

Time Frame

12 weeks

Title

Number of symptomatic Urinary tract infections (UTIs) determined by urine culture.

Description

Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Incidence of bacteremia

Description

Incidence of bacteremia following CA-SUTI

Time Frame

12 weeks

Title

Incidence of Crustation

Description

Incidence of catheter obstruction/encrustation requiring removal

Time Frame

12 weeks

Title

Incidence of Discomfort

Description

Incidence of significant discomfort/pain requiring removal

Time Frame

12 weeks

Title

Surface analysis of the type of bacteria found on each catheter

Description

Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization

Time Frame

12 weeks

Title

Surface analysis of the amount of encrustation

Description

Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation

Time Frame

12 weeks

Title

Surface analysis of the biofilm formation

Description

Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient requires a chronic indwelling Foley catheter for at least 3 days. Catheters will not remain indwelling greater than 30 days at a time Patient is more than 18 years of age Patient is able to give informed consent Patient is able to attend follow-up sessions Exclusion Criteria: Patient is less than 18 years of age Patient is pregnant Patient with a known allergy to silicone Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter Patient unable to accommodate the catheter Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated. Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage) Patient is unable to feel and/or communicate their symptoms Informed consent is unable to be obtained Patient is unable or unwilling to comply with the study follow-up schedule Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study

Facility Information:

Facility Name

Jahn Ferenc South Pest Teaching Hospital

City

Budapest

ZIP/Postal Code

1204

Country

Hungary

12. IPD Sharing Statement

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Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?

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